The Animal
Welfare Regulations and the PHS Policy on Humane Care and Use
of Laboratory Animals (PHS Policy), which implements the
Health Research Extension Act of 1985, require that Animal
Care and Use Committees review and approve significant changes
regarding the use of animals in on- going activities described
in an IACUC approved protocol. The NIH interprets significant
changes to mean those that have the potential to impact
substantially and directly on the health and well-being of the
experimental animals, and thus need review and approval by the
IACUC.

When these
significant changes are planned, researchers must use Form A
to request protocol approval.

To aid
the researchers in fulfilling their responsibilities regarding
changes in approved protocols, the IACUC at Cal State LA
offers the following examples of changes that should be
considered significant:

1.
A change in the overall aims or objectives of the study;

2. A change which may involve
an increase in the levels of pain, distress, and/or
discomfort;

3. A change from non-surgery
to surgery, from minor to major surgery, from non-survival to
survival surgery, or from single to multiple survival surgery;

4. A change in the genus or
species of animals used (provide a rationale for use of the
new species);

5. A change in the personnel
who will be performing procedures involving animals;

6. The addition of the use of
hazardous agents in animal procedures; or

7. A change in the final
disposition of the animals being used in the study.

This list of
examples is not meant to be comprehensive. Whether or not
other modifications are significant is determined by several
factors. It should be understood that changes covering details
beyond what is required in the original protocol are not to be
considered significant, and do not need IACUC review and
approval.